HbA1c - India CDSCO Medical Device Registration

HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_a765b2661b0cb83fc819db077d77dd66_2fab2f4f97f60def4d64854221102336. This device is marketed under the brand name AFIAS Infliximab . The license holder is BODITECH MED INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered

Class Class B

HbA1c

UID: IMP/IVD/2021/000365_a765b2661b0cb83fc819db077d77dd66_2fab2f4f97f60def4d64854221102336

Brand Name

AFIAS Infliximab

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

AFIAS HbA1c is a fluorescence Immunoassay (AFIAS Infliximab ) for the quantitative determination of HbA1c (AFIAS Infliximab ) in human whole blood. It is useful as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus. For in vitro diagnostic use only

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TSH

Brand: AFIAS Infliximab

BODITECH MED INDIA PRIVATE LIMITED

HbA1c - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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TSH

Progesterone

Myoglobin

AMH

Testosterone

IL-6

AFIAS Total Anti-Infliximab

Ferritin

AFIAS Anti-CCP Plus

FSH

TSH

Progesterone

AFIAS-6

Myoglobin

AMH

Testosterone

IL-6

Cardiac Triple

AFIAS Total Anti-Infliximab

AFIAS NORO